Phase
Condition
Constipation
Treatment
TAI Standard-of-Care Treatment
ICE Treatment
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult people (18 yo or older) of any gender
Attending their pre-scheduled on-site visit to the site (The Sir Alan ParksPhysiology & Pelvic Floor Biofeedback Unit | Central Middlesex Hospital) due toconstipation (Symptoms meeting the American College of Gastroenterology definitionof chronic constipation: unsatisfactory defaecation characterized by infrequentstool, difficult stool passage or both for at least previous 3 months.
Bothered by their constipation
Failed biofeedback (in absence of outlet problems)
In waiting list to use TAI
Able to undertake the treatment with the MOWOOT device or TAI themselves, or with acarer willing to do it
Able to understand the study requirements
Able to understand written and spoken English (due to questionnaire validity)
Able and willing to provide written informed consent to participate
Exclusion
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Disease phenotype exclusion criteria:
Irritable Bowel Syndrome with Diarrhoea (IBS-D) or alternating constipation anddiarrhoea (IBSmix): (not due to laxative use)
Inflammatory Bowel Disease (IBD)
Significant outlet problem
Trapping rectocele
Intra anal rectal intussusception
External rectal prolapse
Device-related exclusion criteria:
Abdominal perimeter ≤65cm or ≥130cm
Unable to independently use the MOWOOT technology, unless a carer is available dailyto assist
Other medical conditions, medications and contraindications:
Pregnancy or attempt to become pregnant in the next 6 months.
Previous large bowel resection
Active anorexia or bulimia
Active abdominal cancer
Large inguinal or umbilical hernia
Recent abdominal scars, abdominal wounds or skin disorders that may make abdominalmassage uncomfortable
Any condition that contraindicates abdominal massage.
Significant abdominal pain
Participation in another parallel interventional clinical trial or less than 2months from participation in a previous interventional clinical trial
Planned surgery* if it might be within trial dates (* minor surgery not affectingadherence to treatment is allowed)
Study Design
Study Description
Connect with a study center
The Sir Alan Parks Physiology & Pelvic Floor Biofeedback Unit., Central Hospital, Department of Physiology, St Mark's Hospital, The National Bowel Hospital
London 2643743, London NW10 7NS
United KingdomActive - Recruiting
The Sir Alan Parks Physiology & Pelvic Floor Biofeedback Unit., Central Hospital, Department of Physiology, St Mark's Hospital, The National Bowel Hospital
London, NW10 7NS
United KingdomSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.